Infusion medium delivery system, device and method with needle inserter and needle inserter device and method

• US 7,789,857 B2
• Filed: 12/26/2006
• Issued: 09/07/2010
• Est. Priority Date: 08/23/2006
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Stutz, William H. Jr., Moberg, Sheldon B., Kavazov, Julian D., Hanson, Ian B., Enegren, Bradley J., Bente, Paul F. IV, Griffin, Christopher G., Mounce, R. Paul
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): FLICK, JASON E
• Application Number:
  US11/646,000
• Publication Number:
  US 20080051714A1
• Time in Patent Office: 1,351 Days
• Field of Search: 604/135
• US Class Current: 604/135
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2005/3289 with rotation of the needle, e.g. to ease penetration
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An infusion medium delivery system, device and method for delivering an infusion medium to a patient-user, includes a needle inserter device and method for inserting a needle and/or cannula into a patient-user to convey the infusion medium to the patient-user. The needle inserter device and method operate to insert a needle and cannula into a patient-user'"'"'s skin and automatically withdraw the needle from the patient-user, leaving the cannula in place and in fluid flow communication with a reservoir. The delivery device may include a base portion and a durable portion connectable to the base portion, and wherein the base portion can be separated from the durable portion and disposed of after one or more specified number of uses. The base portion supports the reservoir and the needle inserter device, while the durable portion supports a drive device for selectively driving the infusion medium out of the reservoir and into the needle and/or cannula.

Claims

1. A needle injector device for connection in fluid-flow communication with an inlet or outlet port of a reservoir, the needle injector device comprising:

a housing structure having an interior volume;

a moveable needle supported by the housing structure for movement at least between a retracted position and an extended position;

a needle carriage supported for movement within the interior volume of the housing structure with the moveable needle, at least between the retracted position and the extended position, the needle carriage having a needle passage through which the moveable needle extends in a case where the moveable needle and the needle carriage are in the retracted position;

a hollow needle or cannula attached to the needle carriage and moveable with the needle carriage at least between the retracted position and the extended position, the hollow needle or cannula having a central passage through which the moveable needle extends in a case where the moveable needle, the needle carriage, and the hollow needle or cannula are in the retracted position;

a locking structure for locking the needle carriage and the hollow needle or cannula in the extended position in a case where the needle carriage and the hollow needle or cannula are moved to the extended position;

a first bias member supported by the housing structure within the interior volume of the housing structure, the first bias member for moving the needle carriage toward the extended position;

a lever supported within the interior volume of the housing structure, the lever moveable between a first lever position, in which the lever holds the moveable needle from movement in a direction toward the retracted position, and a second lever position, in which the lever separates from the moveable needle to allow movement of the moveable needle toward the retracted position;

an engagement member for moving the lever to the second lever position as the needle carriage is moved toward the extended position; and

a second bias member operatively coupled to the moveable needle, the second bias member imparting a bias force on the moveable needle in a direction toward the retracted position, the second bias member for withdrawing the moveable needle from at least a portion of the hollow needle or cannula in a case where the needle carriage is in the extended position and the lever is in the second lever position.

2. The needle injector device of claim 1, wherein the housing structure is securable to a patient-user'"'"'s skin and wherein the hollow needle or cannula are located in a position to extend into the patient-user'"'"'s skin, upon the housing structure being secured to the patient-user'"'"'s skin and the needle carriage and the hollow needle or cannula are locked in the extended position.

3. The needle injector device of claim 1,

wherein the housing structure is securable to a patient-user'"'"'s skin, wherein the moveable needle is located in a position to pierce the patient-user'"'"'s skin in a case where the housing structure is secured to the patient-user'"'"'s skin and the moveable needle is moved to the extended position;

and

wherein the moveable needle is located in a position external to the patient-user'"'"'s skin in a case where the housing structure is secured to the patient-user'"'"'s skin and the moveable needle is in the retracted position.

4. The needle injector device of claim 1, wherein the second bias member comprises a spring.

9. The needle injector device of claim 1, wherein the locking structure comprises at least one pivotal or flexible pawl for engaging an engagement surface on the needle carriage upon the needle carriage being moved to the extended position.

10. The needle injector device of claim 1, wherein the needle carriage comprises:

a body having a fluid flow passage in fluid flow communication with the needle passage;

a further hollow needle connected in fluid flow communication with the fluid flow passage and arranged in a position to pierce a septum and be connected in fluid flow communication with a further fluid flow passage that is in fluid flow communication with a reservoir connector.

11. A delivery device for delivery of infusion medium to a patient-user, the delivery device comprising

a reservoir for containing an infusion medium and having an outlet port, a fluid conduit connected in fluid flow communication with the outlet port of the reservoir, a drive device operatively connectable to the reservoir, for selectively driving the infusion medium from the reservoir;

and

a needle injector device according to claim 1, wherein the hollow needle or cannula is connected in fluid flow communication with the fluid conduit in a case where the needle carriage and hollow needle or cannula are in the extended position.

12. A needle injector device of claim 1, the needle injector device further comprising a manual actuator operable from outside of the housing structure, the manual actuator for selectively releasing the needle carriage to move under the force of the first bias member from the retracted position to the extended position.

13. A needle injector device of claim 1, wherein the first bias member comprises a spring.

14. A needle injector device of claim 1, wherein the first bias member comprises a coil spring extending between the needle carriage and an interior surface of the housing structure.

15. A needle injector device of claim 1, wherein the first bias member comprises a rotatable cam having a cam surface imparting a bias force on the moveable needle in a direction toward the extended position as the cam rotates.

16. A needle injector device of claim 15, wherein the rotatable cam comprises a disk-shaped member having a width that varies across its diameter.

23. The needle injector device of claim 1, wherein the first bias member comprises a spring for imparting a bias force on the needle carriage free of external force from outside of the housing.

29. The needle injector device of claim 1, the second bias member for withdrawing the moveable needle from at least a portion of the hollow needle or cannula automatically upon the first bias member moving the needle carriage to the extended position.

31. The needle injector device of claim 1, the lever supported by the needle carnage.

32. The needle injector device of claim 31, the locking structure for locking the lever in the extended position in a case where the needle carriage and the hollow needle or cannula are moved to the extended position.

33. The needle injector device of claim 1, the lever arranged to be in contact with the moveable needle in a case where the lever is in the first lever position.

5. A needle injector device for connection in fluid-flow communication with an inlet or outlet port of a reservoir, the needle injector device comprising:

a housing structure;

a moveable needle supported by the housing structure for movement at least between a retracted position and an extended position;

a needle carriage supported for movement by the housing structure with the moveable needle, at least between the retracted position and the extended position, the needle carriage having a needle passage through which the moveable needle extends in a case where the moveable needle and the needle carriage are in the retracted position;

a hollow needle or cannula attached to the needle carriage and moveable with the needle carriage at least between the retracted position and the extended position, the hollow needle or cannula having a central passage through which the moveable needle extends in a case where the moveable needle, the needle carriage, and the hollow needle or cannula are in the retracted position;

a locking structure for locking the needle carriage and the hollow needle or cannula in the extended position in a case where the needle carriage and the hollow needle or cannula are moved to the extended position;

a bias member operatively coupled to the moveable needle, the bias member for withdrawing the moveable needle from at least a portion of the hollow needle or cannula upon the needle carriage and the hollow needle or cannula being moved to the extended position;

the housing structure including a wall having an opening through which an external plunger may be inserted for imparting a force on the moveable needle in a direction for moving the moveable needle to the extended position, the wall having an interior surface;

the moveable needle comprising a needle head arranged adjacent the interior surface of the wall in a case where the moveable needle is in the retracted position; and

the needle injector device further comprising a seal disposed between and in contact with the needle head of the moveable needle and the interior surface of the wall of the housing structure to provide a seal between the moveable needle and the interior surface of the wall in a case where the moveable needle is in the retracted position.

6. The needle injector device of claim 5, the needle head arranged to be contacted by the external plunger in a case where the external plunger is inserted through the opening in the wall of the housing structure and the moveable needle is in the retracted position.

7. The needle injector device of claim 5, wherein:

at least one of the needle head and the interior surface of the wall includes an annular groove; and

the seal comprising an annular seal disposed at least partially within the annular groove.

8. The needle injector device of claim 7, wherein the other one of the needle head and the interior surface of the wall has an annular protrusion for engaging the annular seal in a case where the moveable needle is in the retracted position.

24. The needle injector device of claim 5, wherein the seal is arranged to abut at least one of the wall and the moveable needle and seal the opening through the wall in a case where the moveable needle is in the retracted position.

25. The needle injector device of claim 5, wherein the seal is arranged to extend around the circumference of the opening in the at least one of the wall and the moveable needle and seal the opening through the wall in a case where the moveable needle is in the retracted position.

26. The needle injector device of claim 5,

the housing having an interior volume;

the opening through the wall of the housing providing access to the interior volume of the housing from outside of the housing; and

the seal arranged to seal the opening through the wall in a case where the moveable needle is in the retracted position.

28. The needle injector device of claim 5, wherein the seal is arranged to provide a seal encircling the opening.

17. A needle injector device for connection in fluid-flow communication with an inlet or outlet port of a reservoir, the needle injector device comprising:

a housing structure;

a moveable needle supported by the housing structure for movement at least between a retracted position and an extended position;

a needle carriage supported for movement by the housing structure with the moveable needle, at least between the retracted position and the extended position, the needle carriage having a needle passage through which the moveable needle extends in a case where the moveable needle and the needle carriage are in the retracted position;

a hollow needle or cannula attached to the needle carriage and moveable with the needle carriage at least between the retracted position and the extended position, the hollow needle or cannula having a central passage through which the moveable needle extends in a case where the moveable needle, the needle carriage, and the hollow needle or cannula are in the retracted position;

a locking structure for locking the needle carriage and the hollow needle or cannula in the extended position in a case where the needle carriage and the hollow needle or cannula are moved to the extended position;

a bias member operatively coupled to the moveable needle, the bias member for withdrawing the moveable needle from at least a portion of the hollow needle or cannula upon the needle carriage and the hollow needle or cannula being moved to the extended position;

a lever moveable between a first lever position, in which the lever holds the moveable needle from movement in a direction toward the retracted position, and a second lever position, in which the lever releases the moveable needle and allows the moveable needle to move toward the retracted position under force of the bias member;

a spring having a coil portion, a first arm, and a second arm, the first arm secured in a fixed relation relative to the housing structure and the second arm moveable from at least between a first position and a second position under a force provided by the coil portion;

wherein the spring is arranged at a location relative to the moveable needle to cause the second arm to apply a force to urge the moveable needle, the needle carriage, and the hollow needle or cannula to the extended position as the second arm moves toward the second position, and to move the lever from the first lever position to the second lever position with continued movement of the second arm toward the second position.

18. A needle injector device of claim 17, wherein the lever comprises a lever mounted for pivotal motion relative to the housing structure.

19. A needle injector device of claim 17, the needle injector device further comprising an actuator for holding the second arm of the spring in the first position and for selectively releasing the second arm of the spring to allow the second arm of the spring to move to the second position.

20. A needle injector device of claim 19, wherein the actuator comprises an operator accessible from outside of the housing structure.

30. The needle injector device of claim 17, the housing structure having an interior volume, the lever supported within the interior volume of the housing structure.

21. A delivery device for delivering fluidic media to a user, the device comprising:

a housing structure adapted to be secured to a user'"'"'s skin;

a reservoir having an interior volume for containing fluidic media, the reservoir having an outlet port, the reservoir operatively connectable to a drive device to selectively drive fluidic media out the outlet port from the interior volume;

a channel having a longitudinal axis extending at least partially through the housing structure and having a first end open toward the user'"'"'s skin in a case where the housing structure is secured to the user'"'"'s skin;

at least one engagement structure;

a cannula and a cannula nest having an engagement surface, the cannula and the cannula nest having a size and shape capable of moving in the channel to an extended position, the cannula extending into the user'"'"'s skin upon the cannula and the cannula nest being in the extended position and the housing structure being secured to the user'"'"'s skin, the engagement surface of the cannula and the cannula nest arranged to be engaged by the engagement structure upon the cannula and cannula nest being in the extended position, to hold the cannula and the cannula nest in the extended position;

a moveable needle supported by the housing structure for movement with the cannula and the cannula nest at least between a retracted position and an extended position;

a bias member for imparting a bias force on the moveable needle in a direction toward the retracted position;

the housing structure including a wall having an opening through which an external plunger may be inserted for imparting a force in a direction for moving the moveable needle, the cannula, and the cannula nest to the extended position at which the cannula and cannula nest are held by the engagement structure, and then releasing the moveable needle to allow the moveable needle to move toward the retracted position under the bias force of the bias member, the wall of the housing structure having an interior surface;

the moveable needle comprising a needle head arranged adjacent the interior surface of the wall in a case where the moveable needle is in the retracted position;

the delivery device further comprising a seal disposed between and in contact with the needle head of the moveable needle and the interior surface of the wall of the housing structure to provide a seal between the moveable needle and the interior surface of the wall in a case where the moveable needle seal is in the retracted position.

22. A delivery device for delivering fluidic media to a user, the delivery device comprising:

a housing structure adapted to be secured to a user'"'"'s skin;

a reservoir having an interior volume for containing fluidic media, the reservoir having an outlet port, the reservoir operatively connectable to a drive device to selectively drive fluidic media out the outlet port from the interior volume;

a needle injector device coupled in fluid-flow communication with the outlet port of the reservoir, the needle injector device for inserting a hollow needle or cannula into the user'"'"'s skin, upon the housing structure being secured to the user'"'"'s skin, the needle injector device comprising;

a moveable needle supported by the housing structure for movement at least between a retracted position and an extended position;

a needle carriage supported for movement by the housing structure with the moveable needle, at least between the retracted position and the extended position, the needle carriage having a passage through which the moveable needle extends in a case where the moveable needle and the needle carriage are in the retracted position;

a hollow needle or cannula attached to the needle carriage and moveable with the needle carriage at least between the retracted position and the extended position, the hollow needle or cannula having a central passage through which the moveable needle extends in a case where the moveable needle, the needle carriage, and the hollow needle or cannula are in the retracted position;

a locking structure for locking the needle carriage and the hollow needle or cannula in the extended position in a case where the needle carriage and the hollow needle or cannula are moved to the extended position;

a first bias member supported by the housing structure within the interior volume of the housing structure, the first bias member for moving the needle carriage toward the extended position;

a lever (supported within the interior volume of the housing structure, the lever) moveable between a first lever position, in which the lever holds the moveable needle from movement in a direction toward the retracted position, and a second lever position, in which the lever separates from the moveable needle to allow movement of the moveable needle toward the retracted position;

an engagement member for moving the lever to the second lever position as the needle carriage is moved toward the extended position; and

a second bias member operatively coupled to the moveable needle, the second bias member imparting a bias force on the moveable needle in a direction toward the retracted position, the second bias member for withdrawing the moveable needle from at least a portion of the hollow needle or cannula in a case where the needle carriage is in the extended position and the lever is in the second lever position.

27. The delivery device of claim 22, wherein the second bias member comprises a spring that provides the bias force on the needle carriage free of external force from outside of the housing.